A Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
NCT ID: NCT04608513
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2020-11-16
2021-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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ACT-1014-6470 single dose (dose level 1)
Soft capsule for oral administration
ACT-1014-6470
Soft capsules for oral administration
Placebo single dose (dose level 1)
Soft capsule for oral administration
Placebo
Soft capsules for oral administration
ACT-1014-6470 single dose (dose level 2)
Soft capsule for oral administration
ACT-1014-6470
Soft capsules for oral administration
Placebo single dose (dose level 2)
Soft capsule for oral administration
Placebo
Soft capsules for oral administration
ACT-1014-6470 multiple dose (dose level 1)
Soft capsule for oral administration
ACT-1014-6470
Soft capsules for oral administration
Placebo multiple dose (dose level 1)
Soft capsule for oral administration
Placebo
Soft capsules for oral administration
ACT-1014-6470 multiple dose (dose level 2)
Soft capsule for oral administration
ACT-1014-6470
Soft capsules for oral administration
Placebo multiple dose (dose level 2)
Soft capsule for oral administration
Placebo
Soft capsules for oral administration
ACT-1014-6470 multiple dose (dose level 3)
Soft capsule for oral administration
ACT-1014-6470
Soft capsules for oral administration
Placebo multiple dose (dose level 3)
Soft capsule for oral administration
Placebo
Soft capsules for oral administration
ACT-1014-6470 multiple dose (dose level 4)
Soft capsule for oral administration
ACT-1014-6470
Soft capsules for oral administration
Placebo multiple dose (dose level 4)
Soft capsule for oral administration
Placebo
Soft capsules for oral administration
Interventions
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ACT-1014-6470
Soft capsules for oral administration
Placebo
Soft capsules for oral administration
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent prior to any study-mandated procedure.
* Healthy male subjects (both study parts) and female subjects of nonchildbearing potential (Part B) aged between 18 and 55 years (inclusive) at Screening.
* Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
* Male subjects with a partner that might become pregnant must either be vasectomized or agree to practice adequate contraception from admission to the study site until 3 months after dosing, or the partner must consistently and correctly use (from Screening, during the entire study, and for at least 3 months after last study treatment intake) a highly effective method of contraception.
Criteria for Part B only:
• Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day-1.
Exclusion Criteria
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.
* Relevant bacterial, viral, fungal, or protozoal infection that manifested within the last 6 weeks prior to Screening and/or ongoing relevant bacterial, viral, fungal, or protozoal infection, as judged by the investigator, and/or evidence of immune dysfunction based on laboratory tests at Screening.
* Any signs or symptoms of active, ongoing infection judged to be clinically relevant by the investigator (special attention should be given to clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, or fatigue).
18 Years
55 Years
ALL
Yes
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Locations
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Parexel International GmbH Klinikum Westend
Berlin, , Germany
Countries
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Other Identifiers
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ID-087-102
Identifier Type: -
Identifier Source: org_study_id